Pronk Technologies SimCube User manual

SimCube™ NIBP Simulator
Operator’s Manual
www.pronktech.com

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SimCube, Pronk, and Pronk Technologies are trademarks of Pronk Technologies Inc.
©2012 Pronk Technologies Inc. All rights reserved
Compliant products conforming to the relevant standards and directives required for
CE have a CE Mark label, as shown below, affixed to the unit. CE Marked products
also comply with the WEEE directive for category 9 Monitoring and Control
Instrumentation products. Do not dispose of this product as unsorted waste. To
dispose, contact Pronk Technologies at [email protected]. A Return Material
Authorization will be issued to return the unit for disposal.

Table of Contents
Contact Us
Sales: 800-609-9802
Technical Support: 800-541-9802 or 818-768-5604
FAX: [phone]
Email: [email protected] for sales
[email protected] for service
Web site: www.pronktech.com
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Getting Started 4
NIBP Detailed Information 6
ECG/RESP Detailed Information 8
IBP Detailed Information (SC-5 Only) 9
Battery Operation 10
SimCube System Troubleshooting Tips 12
Accessories 14
Services 15
Warranty and Service Information 16
Optimizing Simulation Results With Your SimCube Oscillometric 17
NIBP Simulator
SimCube Sample Readings (Back Cover) 24

SimCube™ Operation Instructions
Models SC-1, SC-2, SC-3, SC-4 and SC-5
2. Connect the power jack into the SimCube power receptacle. Many power supplies use the
same plug, and connecting the SimCube simulator to the wrong power supply may damage it. Be
sure the plug has a yellow SimCube flag on it prior to connecting it to the SimCube simulator.
3. Wait for the power-up sequence to complete. When complete, the display will show 000.0
on SimCube models SC-1, SC-2, SC-3 and SC-4 and SC-5 with SW versions up to 4.5. SC-5 SW
version 5.0 or higher will display 0.0. During the power-up sequence, the SimCube simulator will
zero its pressure, so please remove all connections from the NIBP bulkhead to allow the SimCube
to accurately zero to atmosphere. This step may take up to 15 seconds to complete.
4. Select the desired mode by pressing the Yellow Mode button. Each time the Mode button
is pressed, the mode will be changed and the LED indicating the new mode will be lit. If the
SimCube transitions into sleep mode (after approximately 30 seconds of non-use) to conserve
power, the first press of the Mode button will illuminate the display and a second press will be
required to move to the next mode. The NIBP and, if available, ECG, RESP, and IBP values
corresponding to each mode are printed on the front panel next to the LED, horizontally. For more
detailed information on each mode, refer to each parameter section in this manual.
5. For dynamic NIBP testing, connect the SimCube simulator in line with the monitor’s cuff and
hose as shown in Fig. 1. Different monitors will require different adapters. A variety of adapters
are available from Pronk Technologies Inc. and each SimCube system comes equipped with at
least one. Using a SimCube Cuff Jacket can improve reading capture and consistency. Generally,
the smaller cuff jacket sleeve volume is best for most monitors. In Neo mode, be sure to use a
small cuff. To use the Cuff Jacket, wrap the cuff as described above and insert into the desired neo
or large volume sleeve. If not using the Cuff Jacket, wrap cuff snugly around itself and place in an
area safe from accidental motion.
Com +V
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Introduction
Your Pronk TM SimCube TM simulation system is quick to set up, easy to use and ready to go
where you need to be. Your SimCube system comes with the following: The SimCube
simulator, a small 6VDC/2 amp power supply and at least one adapter. For information on other
accessories, visit our web site www.pronktech.com.
Getting Started
1. Plug the SimCube power supply into an AC outlet.
Warning: Use only the power supply provided with your SimCube system. The power supply
provided is 6VDC, 1.8amp, center positive, 2.1mm jack.

!
NIBP Monitor
Fig. 1
6. Start the NIBP reading on the unit under test and wait for the reading to complete.
7. For static calibration, over pressure testing, and leak testing, connect the SimCube
simulator and a manual pump bulb in line with the monitor’s cuff and hose as shown in Fig. 2. All
SimCube models include a manometer for performing static calibration. Some models include an
Over Pressure (peak detect) mode for performing over pressure testing and some models include
a Leak Test mode for performing leak tests.
Fig. 2
!
NIBP Monitor
8. For IBP testing, connect the IBP extension cable supplied with the SimCube system and the
correct IBP adapter for the monitor under test to the SimCube simulator. A variety of IBP adapters
are available from Pronk Technologies Inc. Select the ‘0’ mmHg IBP simulation mode, zero the
monitor, then select the desired simulation mode.
9. For ECG and Respiration testing, connect the ECG cable from the monitor under test to the
SimCube simulator. Snap locations for 3, 5 or 12 lead simulations are indicated on the side of the
SimCube simulator and shown in Fig. 3. When using large snap heads or alligator clips, it may be
necessary to use the ECG Extender Module, which is available from Pronk Technologies Inc.
RA
LA
LL
RL
V1
V2
V4
V3
V5
V6
SimCube Side View Fig. 3
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User Interface Information
SC-4 SimCubes with software version 3.3 and SC-5 SimCubes with software version 4.3 and
above include the ‘Press and Hold’ feature. This feature allows the user to advance through
various simulations in a given mode. To place the SimCube into the Press and Hold mode, press
and hold the Yellow Mode button for two seconds or until the Mode LED begins to flash. Each
press of the Yellow Mode button will advance to the next waveform. As an example, when in HR
Seq, by placing the SimCube in the Press and Hold mode, the HR Seq will stay at 30BPM until the
Yellow Mode button is pressed. Then it will advance to 60BPM. Each subsequent press of the
Yellow Mode button will advance to the next waveform in the sequence. To exit the Press and
Hold mode, simply press and hold the Yellow Mode button for two seconds, or power cycle the
SimCube.
NIBP Detailed Information
Before you begin, make sure you have your SimCube setup as described in ‘Getting Started.’
Available simulation modes are described below. Refer to the front panel of your SimCube
simulator to determine which modes apply to your model.
•NIBP Adult (120/80)
Simulates a patient with blood pressure of 120/80mmHg, heart rate of 70 bpm, mean pressure of
97mmHg, and pulse volume of 1 ml.
•NIBP Neo (70/40)
Simulates a patient with blood pressure of 70/40mmHg, heart rate of 95 bpm, mean pressure of
51mmHg, and pulse volume of 0.25 ml. Requires use of a neo or pediatric cuff and the monitor
under test should be placed in neonatal mode, if available.
• NIBP High (190/120)
Simulates a patient with blood pressure of 190/120mmHg, heart rate of 70 bpm, mean pressure of
142mmHg, and pulse volume of 1 ml.
• NIBP Low (80/40) (SC-5 only)
Simulates a patient with blood pressure of 80/40mmHg, heart rate of 70 bpm, mean pressure of
58mmHg, and pulse volume of 1 ml.
• NIBP Peak Detect / Over Pressure (SC-3, 4 & 5 only)
This mode is used to test the over pressure feature on patient monitors. The SimCube readout
will latch the highest pressure value sensed (in 1mmHg steps). When the input pressure has
returned to 0 mmHg for 15 seconds, the latched value is cleared. Typically the monitor must be
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placed into a test mode so that the software will not release the cuff pressure prior to the over
pressure activating. The trigger point on the over pressure feature of many patient monitors can
depend on the inflation rate, so care should be taken to create an inflation rate which is similar to
that produced by the monitor’s pump with a typical cuff.
• NIBP Manometer
SC-1, SC-2, SC-3, and SC-4: Static Manometer readout displays pressures from 0 to +400mmHg
in 0.1mmHg steps. NIBP simulation is OFF.
SC-5: Static Manometer readout displays pressures from –400 to +400mmHg in 0.1mmHg steps.
NIBP simulation is OFF.
This mode can be used for performing static calibration of NIBP monitors. In many cases the
monitor must be placed in a special test mode so that it will not release the cuff pressure.
• NIBP Leak Test (SC-5 only)
This mode is used for measuring leak rates in NIBP monitors, their cuffs and their hoses. Until it
detects that cuff inflation is complete, leak test mode will simply display the cuff pressure. Once
cuff inflation completion is detected (less then 8mmHg change in a 5 seconds window), leak test
mode will start its elapsed timer. When the elapsed timer reaches 15 seconds (to allow for initial
pressure settling), the display will begin to cycle every 5 seconds showing static pressure,
indicated by P (in mmHg); leak rate, indicated by L (in mmHg per minute); and elapsed time (in
Min:Sec). In many cases the monitor must be placed in a special test mode so that it will not
release the cuff pressure.
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ECG/RESP Detailed Information
Before you begin, make sure you have your SimCube setup as described in ‘Getting Started.’
Available Simulation Modes are described below. Refer to the front panel of your SimCube
simulator to determine which modes apply to your model.
• ECG / RESP rate simulation modes (SC-4, -5 only)
These modes produce NSR ECG waveforms at the rate indicated on the front panel. Respiration
rates are also on the front panel.
• ECG/RESP rate simulation modes (SC-2 only)
These modes produce NSR ECG waveforms at the rate indicated below.
For ECG calibration purposes, the SimCube ECG waveform output is 1 mV on the following lead
/ configuration (software version is displayed on boot up):
• ECG Arrhythmia Simulation mode (SC-5 only)
The Arrhythmia mode is designed to allow you to quickly check that all the life critical ECG alarms
on a patient monitor are properly configured. The mode consists of a single cardiac failure
sequence: 90 seconds of normal beats interspersed with PVCs and Runs, followed by
approximately 30 seconds of VTACH, followed by 30 seconds of VFIB, concluding with 30
seconds of asystole. When the sequence is complete it restarts. RESP value stays at 00bpm.
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NIBP Manometer No ECG
NIBP Adult (120/80) 70/35
NIBP Neo (70/40) 94/47
NIBP (190/120) 70/35
ECG Asystole 0/0
ECG Resp OFF 70/0
ECG Pacer ON 70/35 w/pacer
SC-2 ECG/Resp Values
Calibration
point
SC-5
software
version
SC-4
software
version
SC-2
software
version
1 mV on Lead I Up to 4.1 Up to 3.1 Up to 1.9
1 mV on Lead II 4.2.X and
later
3.2.X and
later
1.10 and
later

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IBP Detailed Information (SC-5 Only )
Before you begin, make sure you have your SimCube setup as described in ‘Getting Started.’ The
IBP interface to the SimCube simulator is a 6 pin mini DIN connector. For compact storage, each
SimCube system is supplied with a single long (6’) extension cable, which can be used with a
variety of short (6”) adapter cables that are sold separately. A variety of adapter cables are
available from Pronk Technologies Inc. as is information to allow you to fabricate your own cables
from the extension cable and an IBP cable you may have on hand. Wiring is as follows: + Excit =
pin 1, - Excit = pin 4, + Sig = pin 3, -Sig = pin 6, which should be compatible with most other mini
DIN IBP simulator cables. Contact Pronk Technologies Inc. at 800/541-9802 for more information.
• IBP Dynamic Modes
The pressure values of dynamic IBP modes match those of the NIBP values associated with the
same mode and are indicated by the arrow on the front panel in the IBP column pointing
towards the NIBP column.
• IBP 0
Use this mode to simulate atmospheric pressure and zero your monitor.
• IBP 100
The IBP 100 Mode will simulate a static 100mmHg which can be used for calibration.
• IBP 200
The IBP 200 Mode will simulate a static 200mmHg which can be used for calibration.
• IBP Step
The Step Mode will step through the following static values for 30 seconds each, then repeat the
sequence: 0, 25, 50, 100, 150, 200, 250mmHg. This allows for a quick but complete check of the
IBP channel over its entire range.
• ECG Pacer (SC-2, 4 & 5 only)
NSR ECG at 70 bpm with pacer signal. RESP output rate is 35 bpm on SC-2 and SC-4 and 0 bpm
on SC-5. This mode is designed to allow testing of a monitor’s pacer detection and artifact
stripping circuitry.
ECG/RESP HR Seq/Alarm Test mode (SC-4 and SC-5 only)
Paired ECG Heart rate and Respiration values will toggle every 30 seconds. ECG values: 30, 60,
90, 120, 45, 60, 160, 220. RESP values: 00, 30, 45, 60, 22, 30, 80, 110. This mode allows quick
and complete testing of a monitor’s cardiotach.

Battery Operation
SimCube models SC-3, SC-4 and SC-5 may be operated on battery power using the Battery
Boost Option. The Battery Boost allows the user to switch between AC power and four “AA”
batteries and it easily integrates with the SimCube padded carrying case. The Battery Boost is
designed to operate with alkaline batteries for simplicity and convenience, however, please note
that using NiMH batteries will provide the highest battery performance. Simulating only NIBP, the
SimCube simulator can perform 100-200 NIBP simulation readings on a set of fresh NiMH
batteries. While rechargeable batteries may be used, an external charger is required to recharge
these batteries.
SC-5 models with software version 5.0 or higher include enhancements to help extend battery life
while using the Battery Boost Option. Please note the following battery saving features in your new
SC-5 as compared to any previous versions you may have:
• The display will be slightly dimmer.
• The SimCube will go into "sleep" mode when the NIBP functions are not in use, the display will
go blank and the green Mode LED will flash.
• When the batteries are depleted, the Battery Level indicator on the Battery Boost will illuminate
a red LED and the SimCube may re-boot to further indicate the need to replace the batteries.
1. CRITICAL OPERATION NOTES. PLEASE READ FIRST!
• You may use NiMH rechargeable batteries, but the Battery Boost does not charge them.
Rechargeable batteries must be charged outside of the SimCube system.
• When the Battery Level indicator lamp is red your simulator may continue to operate, but
values should not be trusted. Always confirm the Battery Level LED is green when doing a
simulation on battery power.
• When your SimCube simulator is not in use, switch the Battery Boost to the “Batt OFF”
position to avoid draining your batteries.
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a. Connect the gray power cable from the Battery Boost to your SimCube
simulator.
b. Insert four “AA” batteries into the battery carriage.
c. Position the switch on the battery module to “Batt ON.” The SimCube simulator
will power on.
3. Operation Guide
a. Battery Operation
Simply Install batteries (alkaline or rechargeable) into Battery Boost and switch to
“Batt ON” position. When you are done using your SimCube simulator switch to
“Batt OFF.” When Batt level LED changes from green to orange, make sure you
have a spare set of batteries on hand. When the Batt Level LED changes from
orange to red, change the batteries. The Batt Level LED will turn orange when
approximately 25% battery life remains (about 50 readings). Always double
check that the switch is in the “Batt OFF” position when you are done; the
numeric display on the SimCube simulator is blanked under certain conditions to
conserve power so you cannot rely on that to indicate that the unit is off.
b. AC Operation
When AC power is available, simply plug the SimCube power supply into an AC outlet. The Battery
Boost will automatically switch over to AC and your batteries will not be drained, regardless of
whether the battery boost slide switch is in the on or off position. The “AC ON” indicator lamp will
light continuously while the AC power supply is connected to a viable AC outlet, but when AC
power is disconnected and the battery is switched on, the “AC ON” lamp may still emit a short flash
every few seconds. During AC operation, the Batt Level LED may not accurately reflect the state
of the batteries.
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2. Installation

SimCube System Troubleshooting Tips
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Accessories
ECG is Noisy
The noise may point to a ground loop issue. Check for
ground loop noise by running the SimCube on battery
power to see if the noise still exists. If it is present, check to
see that the monitor under test has its A/C filter(s) enabled.
Please note that monitors may have more than one filter
that filter out of different frequencies.
ADAPT-FP
Welch Allyn Flexiport style: A snap connector, used on any monitor
with Welch Allyn Flexiport cuff.

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IBP Interface Cable for MDE/Spacelabs Monitors - This cable has a six
pin a mini-DIN
to MDE/Spacelabs style connector. It is six inches long and
works with the IBP-Extension cable.
IBP-EXT
CABLE
IBP Interface Cable for HP Merlin/Philips Monitors - This cable has
a six pin mini-DIN to Merlin style connector. It is six inches long and
works with the IBP-Extension cable.
IBP Interface Cable for Datascope Monitors - This cable has a six
pin mini-DIN to Datascope connector. It is six inches long and works
with the IBP-Extension cable.
IBP Interface Cable for GE/Marquette Monitors - This cable has a
six pin mini-DIN to GE style connector. It is six inches long and works
with the IBP-Extension cable.
IBP Interface Cable for Datex Ohmeda Monitors - This cable has a
six pin mini-DIN to Datex Ohmeda style connector. It is six inches long
and works with the IBP-Extension cable.
IBP Interface Cable for Draeger Monitors - This cable has a six pin
mini-DIN to
Draeger style connector. It is six inches long and works with
the IBP-Extension cable.
IBP Interface Cable for Fukuda Denshi Monitors - This cable has a
six pin mini-DIN to Fukuda Denshi style connector. It is six inches long
and works with the IBP-Extension cable.
IBP-Datex
IBP-Draeger
IBP-Fukuda
IBP Interface Cable for Nihon Kohden Monitors - This cable has a
six pin mini-DIN to Nihon Kohden style connector. It is six inches long
and works with the IBP-Extension cable.
IBP-NK

Services (Please Call For Pricing)
*Pronk Technologies recommends an annual calibration interval.
*Extended Warranty (up to 5 years total) may be purchased only at time of original sale or with
purchase of Rejuvenation Service
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SC-3/4 Upgrade Service

Warranty and Service Information
SimCube Limited Warranty
The SimCube NIBP Simulator with optional ECG/Respiration and IBP feature is warranted against
defects in materials and workmanship for a period of forty-eight (48) months from the date of
shipment to the original purchaser. Warranty is valid only to the original buyer. Defective
equipment should be returned freight prepaid to Pronk Technologies Inc. Equipment returned with
defective parts and assemblies shall be either repaired or replaced at the manufacturer’s sole
discretion. This warranty is not applicable if the unit has been opened, if repair has been
attempted, if the unit has been damaged due to operation outside the environmental and power
specifications for the product, or due to improper handling or use.
If any fault develops, notify Pronk Technologies (see Returns and Repairs, below) giving full
details of the difficulty, and include the model and serial number of the device. Upon receipt of
shipping instructions, forward the device prepaid and repairs will be made at the factory.
The foregoing warranty is in lieu of all other warranties expressed or implied, including but not
limited to any implied warranty or merchantability, fitness or adequacy for any particular purpose
or use. Pronk Technologies shall be liable only for repair or replacement of the SimCube NIBP
Simulator and optional features. Pronk Technologies shall not be liable for any incidental or
consequential damages.
Order Cancellation and Refund Policy
You may return your item within 14 days of delivery for a full refund. We are unable to exchange
items (however, if you received a defective or incorrect item, we will be happy to make an
exchange). Item(s) returned for refund must be in its original condition, undamaged and with no
missing parts, packed in its original packaging, and include both the original receipt and an RMA
number.
We will notify you via e-mail or fax of your refund once we have received and processed the
returned item. You can expect a refund in the same form of payment originally used for purchase
within 7 to 14 business days of our receiving your return.
Returns and Repairs
Please call Pronk Technologies’ Service Department at 800-541-9802 to obtain a Return
Merchandise Authorization (RMA) number and the shipping address. Returns should be
packaged securely in the original packaging materials. The RMA number should be clearly
marked on the packaging. If the return is for a new item and is a result of our error, we will make
arrangements for payment of return shipping. Otherwise, items should be returned freight prepaid
to Pronk Technologies.
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Optimizing Simulation Results With Your SimCube Oscillometric
NIBP Simulator by Karl Ruiter, Pronk Technologies Inc.
Introduction
The SimCube NIBP simulator provides
accurate NIBP simulation in an amazingly
convenient, rugged, and affordable package.
As you use your simulator on various patient
monitors it is important to understand what sort
of results to expect, what they mean, and how
to optimize them.
NIBP Device Accuracy
The accuracy of NIBP devices is governed by
an AAMI standard (SP-10). This standard
specifies two different types of accuracy: static
and dynamic.
The static accuracy represents the accuracy
with which the internal pressure gauge in the
device can measure cuff pressure and it is
required to be within +/-3mmHg or +/-2%,
whichever is greater. The static accuracy of
the device can be easily checked by placing
the monitor in cal or check mode and verifying
the accuracy against the SimCube's
manometer mode.
The dynamic accuracy represents the
accuracy of the device in taking actual readings
on patients, and it is specified in a relatively
vague way. The AAMI specification calls for
automated (device) readings to be taken on a
large group of patients meeting certain criteria
and the results to be compared with manual
readings taken by nurses on the same patients.
The manual and automatic readings are then
compared statistically.
To be acceptable under the standard the
mean error on systolic and diastolic readings
must be no more than 5mmHg and the
standard deviation of the error must be no
more than 8mmHg.
What this means is that, under the specifica-
tion, roughly 68% of all patients must be within
13mmHg of the manual readings, but 5% might
be only within 21mmHg and 1% might be as far
out as 29mmHg. While these specifications
may seem very loose they can be quite difficult
to meet.
The errors in the readings come from several
basic sources:
1.Patient to Patient Physiological Variations:
Different patients have different arterial pulse
shapes, arterial compliance, flesh rigidity and
other factors which simply make the BP cuff
respond differently. The oscillometric signal is
complex and changes not only in size but in
shape with cuff pressure and it is simply slightly
different from patient to patient. Additionally, a
patient's actual BP values are often not
perfectly stable, but change over time, often
during a reading or a series of readings.
2. Extrinsic Noise: During the testing process
patients may be moving or talking. The signal
to noise ratio on the oscillometric signal is
never very good and it does not take very much
additional noise to affect readings.
3. Intrinsic Noise: Even on a perfectly still
patient with perfectly static blood pressure
there would still be significant reading to
reading variations. The biggest factor on this is
sampling error introduced by the cuff pressure
bleed rate or step size. It is no accident that
step-down NIBP monitors step in 8mmHg
steps and the standard deviation of the error is
specified at 8mmHg. In addition to this both
bleeding and stepping introduce pneumatic
noise which can affect the oscillometric signal.
NIBP Device Differences
In manual NIBP readings there is a published
AHA standard for how the readings should be
performed. In practice the process is somewhat
subjective, but at least there is the intent of
uniformity.
With automated NIBP readings the situation is
quite different. The first companies in the
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Oscillometric market patented their technology
and tried to exert some control on the market
by aggressively pursuing patent litigation. The
result of this was not that they were able to
keep any other manufacturers out of the
market, but rather that all manufacturers have
been legally forced to use slightly different
methods. Key differences in these methods
include:
1. Different cut-off frequencies for the AC
channel high pass and low pass filters.
2. Different metrics for measuring pulse size.
3. Different methods for averaging pulse size.
4. Different methods for finding the peak of the
pulse size envelope.
5. Different methods for determining average
cuff pressure on a given pressure step.
6.Different methods and coefficients for
extracting systolic and diastolic pressure from
the pulse size envelope.
7. Different methods of controlling cuff
pressure such as step down, step up, bleed
down, and bleed up.
Since the oscillometric signal is complex and
different for different patients these design
differences can lead to identical results on
some patients and quite different results on
others.
In addition to the design differences several
other factors lead to differences in readings
between manufacturers:
1. Every manufacturer has adjusted their
system based on the data they measured on
their test patient group. Of course, they used
different test patient groups. In theory the
groups are large enough that they should be
statistically identical, but in practice they can
still give different results.
2. Every manufacturer has adjusted their
system based on data which was measured by
the nurses they used to generate the manual
values for comparison. Of course, they used
different nurses. In theory the nurses are all
using the standard method, but in practice the
process is still subjective and different nurses
get slightly different results.
The end result of these differences is that the
various devices do yield similar but slightly
different results on the average, and on any
specific patient the results can be quite
different.
SimCube Simulation Results
The SimCube uses a simple yet effective
mechanism along with a sophisticated variable
pulse shape approach to deliver accurate,
repeatable NIBP simulation. Simulations can
easily yield values within 10% of their labeled
values and with careful setup this can usually
be lowered to 5% or better. The following table
shows values obtainable with careful setup:
ADULT MODE (120/80)
Vendor Reading1
Reading2 Reading3
MDE 120/81 119/81 121/81
HP 121/79 122/80 121/80
Critikon 126/82 119/83 120/84
Datascope 119/76 120/75 118/75
CSI 122/78 123/77 122/77
NEO MODE (70/40)
Vendor Reading1
Reading2 Reading3
MDE 68/42 67/38 67/43
HP 68/38 67/36 67/38
Critikon 71/42 70/42 71/45
HYPERTENSIVE MODE (190/120)
Vendor Reading1
Reading2 Reading3
MDE 187/117 187/118 187/117
HP 206/124 200/128 199/124
Critikon 189/116 190/118 184/120
Datascope 185/106 187/106 186/106
CSI 197/106 197/111 195/109
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Notes:
1. These results were obtained with SimCube
1.5 software. We are constantly improving the
product so future software versions may give
slightly different results.
2. These results represent data taken from
specific models of these manufacturer's
products. We normally expect a given
manufacturer's results to be pretty consistent
across their product line, but different models
and even different software revisions may give
different results. For example an HP
OmniCare with software E.0.1 reads adult
mode diastolic about 10mmHg lower than a
HP Merlin with software 17.52.
3. The readings shown are actual random
samples, but they do not necessarily reflect
worst case.
4. MDE = Escort II SW 4.2.0, HP = Merlin SW
17.52, Critikon = Vitalnet 2200, Datascope =
Accutorr 3, CIS = 506DXNT
Optimizing Your Simulations
The following techniques will help you obtain
the best possible simulation results.
1. Cuff Size Selection. Many vendors are
immune to variations in cuff size, but some are
not. For example we find that some Datascope
Accutorr monitors produce systolic values
about 2mmHg higher and diastolic values
about 6mmHg higher with a 400ml cuff volume
rather than a 200ml cuff volume, while some
Critikon monitors show about a 6mmHg drop
in systolic values when changing to the 400ml
cuff volume. We recommend using something
close to a 400ml cuff volume for adult mode
simulation. This can be achieved by wrapping
an adult cuff on itself to form a cylinder
approximately 3 inches in diameter. If you
want to quantify the volume of a rolled cuff you
can do this by injecting a measured amount of
air into an unrolled, empty cuff using a syringe
and a check valve. Once you have injected
the desired amount of air, roll the cuff tightly.
SimCube adult mode simulation will normally
work with a broad range of test volumes, but
with smaller test volumes you may see more
vendor to vendor reading differences.
2. Be prepared to throw out the first reading.
We find that some vendors sometimes produce
a first reading that is substantially different than
later readings.
3. Take an average of several readings. We
suggest using a minimum of 3 to 5 readings.
4. Make sure there are no leaks. You can
usually see leaks just by watching the SimCube
manometer during the reading. On step down
systems the cuff pressure may normally drop a
bit during the first few steps, but after a few
steps it should be flat or even rise slightly during
the step. This is because the air in the cuff is
cooled by the rapid step deflation and warms up
again during the step holding period causing
the pressure to rise slightly. A leak on a step
down system will appear as drop in pressure on
all steps. Bleed down systems should normally
bleed at about 2 to 6mmHg per second. A leak
on a bleed down system will appear as a faster
than normal bleed rate. Since the SimCube's
NIBP simulation creates pulses which are
several mmHg in size it is easiest to check for
leaks with the SimCube in manometer mode.
Be sure to watch for leaks on the SimCube's
manometer rather than the monitor's cuff
pressure display as the SimCube has a much
faster sample rate and display update rate than
most NIBP monitors.
5. Make sure the monitor is in calibration.
On monitors with quickly updating cuff pressure
displays you can do a rough cal check by simply
placing the SimCube on top of the monitor,
placing the SimCube in manometer mode, and
starting a reading. The two pressure gauges
should track tightly, although the monitor's
display may be noticeably delayed. On some
monitors, however, the displayed pressure may
represent the intended pressure for the
pressure step rather than the actual pressure.
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If this is the case you cannot use this method.
Neo Mode Simulation Setup
In a neonatal NIBP setup the patient cuff may
represent just a few ml of volume, while the
patient hose may represent 50 ml or more of
volume. Since the SimCube operates by pulse
volume (about 1/4 ml at peak in neo mode) the
pressure pulses can be much larger on single
lumen than on dual lumen systems. Some
single lumen systems do not have enough
dynamic range to reliably capture the pulses
produced by the SimCube with a #1 neo cuff.
While we have had good results with a #2 neo
cuff, we recommend using a loosely wrapped
#3 neo cuff for neonatal simulation on single
lumen systems. Dual lumen systems should
work reliably with a #1 neo cuff.
Due to the reduced pulse size of our neonatal
simulation many monitors will not be able take
readings on this simulation if the monitor is in
adult mode or if you are using an adult cuff. We
strongly recommend using a neonatal cuff and
placing the monitor in neonatal mode.
However, if you do not have access to a
neonatal cuff, any volume in the range to 15 to
75ml will work with most monitors. This can be
achieved with an infant cuff or, in some cases,
with a tightly rolled child cuff. Also, a length of
tubing can be used. A rough but handy
approximation is that a 1 inch length of 1/8 inch
I.D. tubing is around 1ml in volume.
Reading to Reading Variations
Even with the best setup there is still variation
from reading to reading. Sometimes a reading
will be produced which is quite far off target and
it is difficult to know if this represents a problem
with the monitor or not. The AAMI spec says
that 1% of readings can be as much as
29mmHg off, but under simulation, and using
the techniques we have described you should
see much less than that. The following chart
shows some typical error distributions. These
represent the difference from 120mmHg
systolic using SimCube's adult
mode with a 400ml Cuff, discarding the first
reading, for 50 readings. On some monitors
systolic and diastolic have similar error
distributions, while on others they are quite
different.
!
"
# !
# "
$ !
$ "
% !
% "
& !
& "
MDE HP Critikon
<2mmHg
2-3mmHg
4-5mmHg
6-7mmHg
8-9mmHg
10+mmHg
About The Author
Karl Ruiter has been an engineer, a manager,
and a director at a Los Angeles-based medical
device manufacturer where he designed a
NIBP algorithm which is in use in tens of
thousands of units worldwide. This algorithm
has been shown by competing manufacturers
to be one of the most consistent and
noise-immune on the market. In 2003 he
helped to found Pronk Technologies Inc, which
bases its product line on the concept that
biomedical engineers do important work and
they should have really good tools. He was
the lead engineer on the SimCube product.
More Info
More information about the SimCube and
NIBP simulation can be found:
On the Web at: www.pronktech.com
By email at: [email protected]
By phone at: [phone]
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PRONK TECHNOLOGIES